GLP-1 Loading During Elective Percutaneous Coronary Intervention (GOLD-PCI)

June 5, 2018 updated by: Papworth Hospital NHS Foundation Trust

A Study to Investigate the Protective Effects of Glucagon-like Peptide-1 (GLP-1) in Patients Undergoing Elective Angioplasty and Stenting (GOLD-PCI)

Angina is caused by narrowings or blockages within coronary arteries. Coronary angioplasty and stenting is performed for people with angina to improve the blood supply to the heart by placing metal tubes within the artery using balloon inflation. The procedure risks small but significant damage to the heart muscle downstream of the balloon.

Glucagon like peptide 1 (GLP 1) is a naturally occurring hormone secreted by cells in the gut in response to food. It acts by stimulating the release of insulin. In the heart it acts to increase glucose uptake into cardiac muscle. GLP-1 can protect the heart and improve heart muscle performance in people with coronary artery disease in physiological studies. This study which assesses whether GLP-1 protects the heart during coronary angioplasty and stenting.

The hypothesis is that GLP-1 given during elective coronary angioplasty and stenting will reduce cardiac troponin rise (a measure of heart muscle damage) compared to placebo.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
        • Papworth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Undergoing elective PCI
  • Age over 18
  • Able to give informed consent

Exclusion criteria:

  • Severe co-morbidity (expected life expectancy < 6 months)
  • Nicorandil, glibenclamide, sitagliptin, vildagliptin, saxagliptin, linagliptin, liraglutide, exenatide and insulin use
  • Women of child bearing age
  • Breast-feeding women
  • Myocardial infarction within the previous 3 months
  • Baseline elevation of Troponin I before PCI
  • Chronic Renal Impairment (serum creatinine > 160 μmol/l)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Normal Saline
Infusion of Normal Saline during Percutaneous Coronary Intervention
Drug: placebo
Normal saline
EXPERIMENTAL: GLP-1
Infusion of GLP-1 (7-36) amide during elective percutaneous coronary intervention
Drug: GLP-1
GLP-1 (7-36) amide infused at 1.2 pmol/Kg/min
Other Names:
  • GLP-1 (7-36) amide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Troponin I level
Time Frame: 6 Hours following angioplasty or stenting
Incidence of Troponin I elevation of > 5 x 99th percentile upper reference limit on blood test at approximately 6 hours post procedure.
6 Hours following angioplasty or stenting

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular or Cerebrovascular Event (MACCE) Rates
Time Frame: From date of randomisation until the date of first event assessed up to 6 months
MACCE rate (death, stent thrombosis, myocardial infarction, acute coronary syndrome, hospitalisation with heart failure, stroke)- these will be patient reported and confirmed by interrogation of hospital records and interrogation of local and national databases.
From date of randomisation until the date of first event assessed up to 6 months
Plasma Creatine Kinase - Myocardial Bound (CKMB) level
Time Frame: 6 hours
CKMB level on blood test at 6 hours following angioplasty or stenting
6 hours
Myocardial Flow Grade after Angioplasty or Stenting
Time Frame: Measured during procedure
Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale
Measured during procedure
MACCE Rates
Time Frame: From date of randomisation until the date of first event assessed up to 12 months
MACCE rate (death, stent thrombosis, myocardial infarction, acute coronary syndrome, hospitalisation with heart failure, stroke)- these will be patient reported and confirmed by interrogation of hospital records and interrogation of local and national databases.
From date of randomisation until the date of first event assessed up to 12 months
MACCE Rates
Time Frame: From date of randomisation until the date of first event assessed up to 60 months
MACCE rate (death, stent thrombosis, myocardial infarction, acute coronary syndrome, hospitalisation with heart failure, stroke)- these will be patient reported and confirmed by interrogation of hospital records and interrogation of local and national databases.
From date of randomisation until the date of first event assessed up to 60 months
Ischaemic symptoms during balloon occlusion
Time Frame: Assessed during procedure
Presence or absence or of symptoms of myocardial ischaemia during the procedure
Assessed during procedure
Myocardial Blush Grade following angioplasty or stenting
Time Frame: Measured during procedure
Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale
Measured during procedure
Electrocardiographic (ECG) Changes during procedure
Time Frame: Assessed during procedure
Presence or absence of ECG changes reflective of myocardial ischaemia during the procedure
Assessed during procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papworth Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Stephen Hoole, MA MD FRCP, Papworth Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

March 31, 2017

Study Completion (ANTICIPATED)

July 1, 2021

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (ESTIMATE)

May 1, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 5, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P01799

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe